One-time use expandable speculum

ABSTRACT

Expandable specula devices and methods are disclosed. In one aspect, a speculum includes inner and outer balloon layers configured to expand circumferentially. The inner and outer balloon layers form a sealed cavity configured to hold a liquid. The speculum further includes an access tube for injecting the liquid into the cavity. The speculum further includes a shape memory alloy layer within the outer balloon layer. The shape memory alloy layer is configured to transition to a first shape when heated above a transition temperature.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Patent Application No.62/717,388, filed Aug. 10, 2018, entitled EXPANDABLE SPECULUM, thedisclosure of which is incorporated herein by reference in its entirety.

FIELD

One-time use, expandable specula and associated methods are disclosedherein.

BACKGROUND

Health care providers employ specula (speculums) for pelvic examinationsand treatment. For example, physicians use specula when screening forcervical cancer and sexually transmitted diseases (STDs). Specula arealso used when evaluating patients for pain, bleeding and discharge.Such examinations and treatments are important for maintaining women'shealth and prevention of cancer.

Every two minutes a woman dies from cervical cancer. Over 80% of thesewomen are from low to middle income countries. One of the majormotivations for the disclosed technology is to provide a more practicalscreening tool for these women, in helping our mission to improve thescreening and treatment of cervical cancer. Cervical cancer oftenresults from infection by human papilloma virus (HPV), a communicabledisease that is easily communicated between humans, or from inanimateobject to humans. Medical equipment, including specula, may not besufficiently cleaned or sterilized between patients, resulting in thespread of HPV, human immunodeficiency virus (HIV), other viruses,microbes, and other source of disease, from one patient to another.

Traditional specula include an anterior blade and a posterior blade,which push the anterior and posterior vaginal walls out of the field ofview of a clinician during a pelvic examination or treatment. However,traditional billed specula do not retract vaginal walls laterally. Thiscauses visualization problems when examining multiparous patients, obesepatients, patients with a redundant vaginal wall, and patients withpelvic organ prolapse. The examiner will have a difficult timevisualizing the cervix or gaining easy access to the cervix duringexamination and treatment, creating technical difficulties for theclinician, and pain and embarrassment for the patient. Moreover,traditional specula used throughout the world are made of metal or hardplastic.

In a colposcopy clinic, among other options, the most common treatmentfor cervical pre-cancers is a loop electrosurgical excision procedure(LEEP), which involves using a hot wire loop to excise part of thecervix. This procedure cannot be done using a metal speculum. Aspecially coated speculum is used during this procedure which is costly.Additionally, during this procedure, lack of retraction of the lateralvaginal walls due to the shape of the current speculums poses greatdifficulty on the physician during the procedure.

Moreover, traditional double billed specula may be painful anduncomfortable for patients, as they may be cold, rigid, large, and clickduring use. Such discomfort may cause some patients to avoidexaminations, resulting in undetected and therefore untreated infectionsor conditions. After age 40, women often have prolapsed vaginal walls,which partially blocks the view of the health provider. This is oftenexacerbated by obesity. Therefore, there is a need for a speculum thatenables a better view, that does not transmit infection, that is notpainful, and that is comfortable for patients.

SUMMARY

Aspects of the current subject matter relate to a speculum. The speculumincludes an outer balloon layer configured to expand circumferentially.The speculum includes an inner balloon layer configured to expandcircumferentially. The inner balloon layer is formed within the outerballoon layer. The outer balloon layer and the inner balloon layer forma sealed cavity configured to hold a liquid. The speculum furtherincludes an access tube for injecting the liquid into the cavity. Thespeculum further includes a shape memory alloy layer within the outerballoon layer configured to transition to a first shape when heatedabove a transition temperature.

In some variations one or more of the following features can optionallybe included in any feasible combination. For example, at least a portionof the inner balloon layer may be translucent. The shape memory alloymay comprise nitinol. The inner balloon layer may have a more rigidstructure than the outer balloon layer. The outer balloon layer maycomprise latex, rubber, silicon, or a flexible plastic. The speculum mayfurther includes rods incorporated into the outer balloon wall in alongitudinal direction. The rods may be flexible. The rods may comprisesilicon. The shape memory alloy layer may comprise a mesh. The shapememory alloy layer may abut the inner balloon layer. The shape memoryalloy layer may surround the inner balloon layer. The inner balloonlayer may surround the shape memory alloy layer. The outer balloon layermay surround the shape memory alloy layer. The outer balloon layer mayabut the shape memory alloy layer. The speculum may further include anapplicator configured to insert the speculum into a vaginal canal. Thespeculum may further include a valve to regulate a flow of fluid from asyringe into the access tube.

The details of one or more variations of the subject matter describedherein are set forth in the accompanying drawings and the descriptionbelow. Other features and advantages of the subject matter describedherein will be apparent from the description and drawings, and from theclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an expandable balloon speculum inside an applicator forinserting the speculum into the vaginal canal of a patient.

FIG. 2 depicts an expandable balloon speculum, with a tube insertionsite for inserting fluid between the inner and outer layers of theballoon speculum to expand the speculum circumferentially.

FIG. 3 depicts an expandable balloon speculum with a syringe forinserting fluid into a tube insertion site of the expandable balloonspeculum.

FIGS. 4A-4D illustrate that in various embodiments, the shape memoryalloy mesh layer may be interior to the inner balloon layer, as shown inFIG. 4A, between the inner and outer balloon layers abutting the innerballoon layer, as shown in FIG. 4B, between the inner and outer balloonlayers abutting the outer balloon layer, as shown in FIG. 4C, or betweenthe inner and outer balloon layers without abutting either the inner orouter balloon layers, as shown in FIG. 4D, as follows.

FIG. 4A is a cross section of an expandable balloon speculum with anouter balloon layer surrounding an inner balloon layer. The innerballoon layer surrounds and abuts a shape memory alloy mesh layer.

FIG. 4B is a cross section of an expandable balloon speculum with anouter balloon layer surrounding a shape memory alloy mesh layer. Theshape memory alloy mesh layer surrounds and abuts the inner balloonlayer.

FIG. 4C is a cross section of an expandable balloon speculum with anouter balloon layer abutting and surrounding a shape memory alloy meshlayer. The shape memory alloy mesh layer surrounds an inner balloonlayer.

FIG. 4D is a cross section of an expandable balloon speculum with anouter balloon layer surrounding a shape memory alloy mesh layer. Theshape memory alloy mesh layer surrounds the inner balloon layer. Theshape memory alloy mesh layer is between but does not abut either theinner balloon layer or the outer balloon layer.

FIG. 5 is a perspective of a speculum showing a flared shape metal alloymesh. The mesh may be incorporated in specula with cross sectionscorresponding to FIGS. 4A, 4B, 4C, and 4D. For clarity, FIG. 5illustrates a specula with a cross section corresponding to FIG. 4B,since the mesh would be further obscured in perspectives of speculacorresponding to the cross sections of FIGS. 4A, 4C, and 4D by the innerballoon layer.

FIG. 6 is a perspective of the speculum of FIG. 5 before pumping influid from a syringe.

FIG. 7 is a perspective of the speculum of FIG. 6 after pumping in fluidfrom the syringe. The expansion may occur because of heat expansion ofthe shape memory alloy, insertion of the fluid, or some combination ofthe heat expansion of the shape memory alloy and the inserted fluid.

FIG. 8A illustrates an example of shape memory alloy mesh.

FIG. 8B illustrates another example of a shape memory alloy mesh.Various implementations may include the mesh structure of FIG. 8A, themesh structure of FIG. 8B, or another mesh structure.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present disclosure.

Specula are for a wide range of examination procedures, includinggeneral pelvic exam, screening for pelvic infections, cervical cancerscreening, screening for vaginal bleeding, any cancer of the femalepelvis, pelvic organ prolapse, colposcopy, any gynecological procedurethat mandates biopsy or sampling of the internal pelvic organs,endometrial biopsy. In addition to examinations, specula are used for awide range of surgical procedures and in office treatments, includingvaginal hysterectomy, loop electrosurgical excision procedure (LEEP),endometrial ablation, vaginal hysterectomy, hysteroscopy, polypectomy,and in vitro fertilization procedures.

Traditional specula have upper and lower bills that apply upward anddownward pressure to a patient's vaginal canal to open a viewing andexamination pathway for pelvic examination and treatment. Unlike doublebilled specula, expandable balloon specula may be inserted using anapplicator, similar to insertion of a tampon, before the balloon speculaexpands.

With traditional specula, surgeons have to be very careful to avoidcontact between metal blades and hot wire loops or cautery tips, asmetal blades may conduct heat and burn a patient. Unlike metal billedspecula, expandable balloon specula feature an inner balloon layer thatdoes not conduct heat, reducing the possibility of inadvertently burninga patient.

The balloon specula may include inner and outer balloon layers that aresealed, with a cavity between the balloon layers that may be filled witha fluid or gas, causing the balloon to expand. The balloon speculum maybe an annular balloon that is smoothly expandable so as to apply anoutwardly-directed radial force against the vaginal soft tissue in equaldistribution from the vaginal introitus (opening) all the way to the endof the patient's vagina where the cervix is found. The inner and outerannular balloon walls are made of a flexible resilient material withelastic properties to permit expansion of the vaginal wall in acircumferential manner. In various embodiments, the expandable balloonspectrum may include baffles to support this circumferential expansion.In various embodiments, the expansion may be substantially uniform. Invarious embodiments, the expansion may be non-uniform due to, forexample, the shape of a patient's vaginal canal or the design of aspeculum.

The inner balloon layer may have a more rigid structure than the outerballoon layer. The rigid structure may prevent the speculum from foldingin upon itself and maintain a tubular shaped lumen during examinationand treatment. This is particularly useful during the examination of apatients with vaginal wall prolapse.

The balloon can be filled with fluid like water, normal saline, or achemiluminescent fluid. The chemiluminescent fluid not only helps inexpending the balloon walls but also functions as a light sourcedirectly in the vagina, therefore eliminating the need for an outsidelight source which typically requires electricity. This is particularlyuseful in the low to middle income countries where access to electricitymay be a challenge.

The light emitted by a chemiluminescent fluid may be of a color, orcontain wavelengths, to assist with particular examinations orscreenings.

The expandable balloon speculum may also include a shape memory alloymesh layer, which expands when heated by the body heat from a patientsvaginal canal.

The shape memory alloy mesh layer may be within the inner balloon layerand abutting the inner balloon layer, or between the inner and outerballoon layer. Shape memory alloy mesh layers that are between the innerand outer balloon layer may abut the inner balloon layer, abut the outerballoon layer, or not abut either layer, when the balloon speculum isexpanded. Two layers abut when they are either in direct contact, areaffixed to one another, or in manufacturing are integrated with oneanother.

After the expandable balloon speculum is inserted into a patient'svaginal canal, it expands due to shape memory alloy heating, or pressureexerted by fluid injected between the inner and outer layers via aninput tube. Once expanded, a lumen having a tubular shape, within theinner balloon layer, affords a channel for examination and treatment.

Ambient lighting is generally not sufficient for an examination. Invarious embodiments, a chemiluminescent fluid fills at least a portionof the cavity between the inner and outer balloon layers. In variousembodiments, at least a portion of the expandable balloon lumen issufficiently translucent for light emitted by the chemiluminescent fluidto illuminate the vaginal canal and/or cervix of a patient. In variousembodiments, the chemiluminescent fluid fills a component separate fromthe speculum. For example, the chemiluminescent fluid may fill a tube orrod that may be inserted into the lumen of the speculum to illuminatethe vaginal canal.

The specula described herein have certain advantages over traditionalspecula.

A first advantage, in some embodiments, is that the specula are for onetime use, so that each speculum may be unwrapped and sterile for eachuse, thereby preventing the spread of HPV, HIV, microbes, viruses, orother infective agents.

A second advantage, in some embodiments, is that the specula are balloonspecula that expand circumferentially after insertion into the vaginalcanal. As a result, smaller specula, for example, the size of a tampon,with a diameter of 1 cm-2 cm, may be inserted into the vaginal canal.The balloon speculum may then be gently inflated or expanded to acircumference sufficient for a health care provider to perform anexamination. This allows for insertion of a smaller speculum than atraditional speculum.

A third advantage, in some embodiments, is that the specula expand andapply pressure to the vaginal walls circumferentially, as opposed totraditional specula that apply pressure using the top and bottom billsof a speculum. The circumferential pressure is applied all around thecanal, including laterally, instead of just above and below thespeculum. This improves the pressure distribution within the vaginalcanal during examination. The balloon speculum may be expanded graduallyand more comfortably for the patient.

A fourth advantage, in some embodiments, is that the specula do not“click” or make the clicking noise associated with traditional specula,because the specula described herein expand circumferentially, and donot rely on mechanical opening of bills.

A fifth advantage, in some embodiments, is that the specula may beinserted with a tampon-like applicator, which allows the balloon's tipto touch the cervix which is located at the distal end of the vaginalcanal, and then the applicator may be withdrawn. This allows for morecomfortable and proper placement of the balloon speculum prior to itsexpansion. This process may be significantly more comfortable for apatient than insertion and placement of a double billed speculum, whichoften requires moving the double billed speculum, with open blades, backand forth to find the cervix.

A sixth advantage, in some embodiments, is that the specula have acontinuous exterior surface and no bills. This decreases the possibilityof pinching tissue, or catching hair, further increasing comfort for thepatient.

A seventh advantage, in some embodiments, is that the specula have anouter balloon layer formed of a smooth, soft surface, such as a latex,rubber, silicon, or flexible plastic, which may be more comfortable thantraditional specula with more rigid, and possibly cold, surfaces.

An eighth advantage, in some embodiments, is that the specula are atleast partially filled with a chemiluminescent (CI) fluid that providesillumination once the speculum is inserted into the vaginal canal. Thisenables the physician to see, for example, the patient's vagina, cervixor other anatomical detail during a pelvic examination or treatment.This obviates the need to rely on a lamp or handheld light source, suchas a flashlight.

An ninth advantage, in some embodiments, is that the specula include amesh, layer, bars, or other structural elements formed of a shape memoryalloy, such as the nickel titanium alloy nitinol. Nitinol exhibits ashape memory effect, and has superelastic properties. These propertiesmake it possible to, for example, introduce a “compressed” mesh into aspeculum into a vaginal canal, but once nitinol warms through thetransformation temperature from being inside the vaginal canal, thespeculum may expand to the undeformed, expanded mesh shape.

A tenth advantage, in some embodiments, is that the specula provide abetter view for the health care provider than is possible withtraditional specula, particularly for patients with a pelvic organprolapse, and/or who are obese, because the prolapsed vaginal walls areprevented from encroaching on the viewing area by prolapsing through thelateral sides of open blades.

FIG. 1 depicts an expandable balloon speculum 100 inside an applicator700 for inserting the speculum 100 into the vaginal canal of a patient.The applicator 700 includes a chamber 710 that houses a speculum 100, aplunger 720 that, once depressed, projects the speculum 100 out of thechamber 710 through the tip 730 of the applicator 700. The exterior ofthe chamber 710 may be formed of cardboard or plastic, similar tomaterials used in tampon applicators, to facilitate insertion of thedeflated balloon speculum. An access tube 170 to inject fluid into thespeculum 100 may extend from speculum 100. The diameter of theapplicator 700 may vary based on the size of the vaginal canal of thepatient. For example, the applicator 700 may have a diameter of about0.5 cm to about 2 cm. The length of the applicator may be about 10 cm toabout 20 cm.

In various embodiments, the expandable speculum may include thinsemiflexible rods incorporated into the outer balloon wall in alongitudinal fashion. The rods may be formed of silicon, or anotherflexible material. The rods may be arrayed in parallel, and in closeproximity to each other, to allow for consistency in the shape andelasticity of the deflated speculum to facilitate insertion of adeflated balloon speculum into the vaginal canal. When the applicatordeploys the unexpanded speculum in to the vagina, retraction of theapplicator will not cause the balloon speculum to collapse or get stuckin a corner of the vaginal wall.

FIG. 2 depicts an expandable balloon speculum 100. The balloon speculum100 includes an outer balloon layer 110 and an inner balloon layer 120.A cavity 130 formed by the inner balloon layer 110 and outer balloonlayer 120 includes an access tube 170 for injecting a gas or a fluidinto the cavity 130 to expand the balloon speculum 100. The access tube170 may be a flexible tube. For simplicity, the figures depict a shortaccess tube 170, but the flexible tube may extend to a length varyingfrom the diameter of the speculum to several meters.

The speculum 100 has a proximal end 150 and a distal end 160. The distalend 160 may be inserted into a patient's vaginal canal until it comesinto contact with or is in close proximity to a patient's cervix. Whenexpanded, as shown in FIG. 2 , the speculum 100 forms a tube shapedlumen 140 through which a health care provider may view a patient'scervix, for example. In addition, a healthcare provider may insert toolsfor treatment into the lumen 140, from the proximal end 150 (proximal tothe healthcare provider upon insertion into the patient's vaginal canal)to the distal end 160, for a procedure on, for example, a patient'scervix.

FIG. 3 depicts the expandable balloon speculum 100 of FIG. 2 , with asyringe 200 for inserting fluid into a tube insertion site of theexpandable balloon speculum 100. As discussed with respect to FIG. 2 ,the speculum 100 includes an outer balloon layer 110, an inner balloonlayer 120, and a cavity 130 between the inner balloon layer 120 and theouter balloon layer 110. A fluid may be injected into the cavity 130 viathe access tube 170. The expanded balloon speculum 100 forms a tubularlumen 140, through which a health provider may view, for example, apatient's cervix at the distal end of the lumen 140. A valve 180controls the flow of fluid from the syringe 200 through the access tube170 into the cavity 130. The syringe 200 expels fluid from the syringetip 210, into the insertion end 190 of the access tube 170. The syringebody 215 receives a plunger 220, that, when depressed, pushes fluid outof the syringe liquid cavity 230. The syringe body 215 may includevolume markings 240. The fluid injected from the syringe 200 into thespeculum 100 may be water, saline, a chemiluminescent fluid, air, oranother liquid, gas, or gel-like substance.

Chemiluminescence is the emission of light as the result of a chemicalreaction. When chemiluminescent (CI) fluids combine, the ensuingreactions emit light. In various embodiments, the CI fluid reactionsgenerate little heat, to avoid heating the speculum and vaginal canal.The combined fluids or solutions may be separated until light isdesired, at which time they are mixed to form a chemical reaction thatproduces light.

In various embodiments, the first solution is luminol, and the secondsolution is hydrogen peroxide. In various embodiments, the firstsolution is (9,10-diphenylanthracene (blue) dissolved in diethylphthalate, rubrene (5,6,11,12-tetraphenyltetracene; yellow) dissolved indiethyl phthalate, or a mixture (50:50 or otherwise) of9,10-diphenylanthracene and rubrene (white) dissolved in diethylphthalate, as well as bis (2,4,6-trichlorophenyl) oxalate, and sodiumacetate, and the second solution is hydrogen peroxide. In variousembodiments, the first solution is luminol (blue), sodium carbonate,copper sulfate, and ammonium carbonate, and the second solution ishydrogen peroxide.

In various other embodiments, the first solution could be anycombination of luminol and its derivatives, aridinium esters (forexample, lucigenin), anthracene or its derivatives, indoles,polydimethylaminoethylenes, Schiff bases, peroxyoxalates, fluorophores(polycyclic aromatic hydrocarbons), derivative compounds withfluorophores, permanganates, hypochlorites, or iodates, including justone or any number of these components. In various embodiments, thesolutions could be aqueous, organic, or a mixture, such as an emulsion.In other embodiments, the solutions could contain colloidal particles,such as nanoparticles.

Several different mechanisms may be employed to store and mix thesolutions, before inserting them into the syringe. Alternatively, anadditional component, such as a rod or glow stick, could be used as alight source. A glass tube within a plastic tube may be broken, withoutbreaking the plastic tube, by bending the plastic tube containing theglass tube enough to break the glass, but without breaking the plastictube. This would cause a first solution stored in the glass tube to mixwith the second solution stored in the plastic tube, causing a reactionthat emits light when the two solutions mix.

Another storing and mixing mechanism uses two balloons, one inside theother, for which the interior balloon is smaller, thinner, and/or weakerthan the exterior balloon. For example, the interior balloon may havethinner walls and/or be tightly filled. Distortion of the balloons maycause the interior balloon to rupture, while leaving the exteriorballoon intact. This would cause the two solutions, stored in theinterior and exterior balloons, respectively, to mix, causing a reactionthat emits light.

Another storing and mixing mechanism may include a receptacle with aseptum that allows injection of the two solutions into a cavity, so thatthe previously separate solutions mix and cause a reaction that emitslight.

In various embodiments, a chemiluminescent effect may be generated by anelectric current, or ultrasonic stimulation, to solutions that emitlight in the presence of electric current or ultrasonic stimulation.

FIGS. 4A-4D illustrate placement of shape memory alloy mesh layer. Ashape memory alloy, such as the nickel titanium alloy nitinol, may beformed into a mesh, bars, or a skeletal structure. Shape memory alloys,such as nitinol, exhibit a shape memory effect, and has superelasticproperties. The shape memory effect is the ability to undergodeformation at one temperature, and then recover its original,undeformed shape upon heating above a transition temperature. Thetransition temperature of nitinol varies depending on the composition ofthe alloy. For example, temperatures between about 30° C. (86° F.) andabout 130° C. (266° F.) are possible. For specula, a transitiontemperature between about 30° C. (86° F.) and body temperature, about37° C. (98.6° F.), may be used. Superelasticity occurs at a narrowtemperature range above the transition temperature, so that furtherheating is not necessary to cause the undeformed shape to recover itsshape. Nitinol exhibits elasticity that is an order of magnitude greaterthan that of ordinary metal.

There are a variety of alloys with shape memory effects. They includeAg—Cd 44/49 at. % Cd, Au—Cd 46.5/50 at. % Cd, Co—Ni—Al, Co—Ni—Ga,Cu—Al—Ni 14/14.5 wt. % Al, 3/4.5 wt. % Ni, Cu—Al—Ni—Hf, Cu—Sn approx. 15at. % Sn, Cu—Zn 38.5/41.5 wt. % Zn, Cu—Zn—X (×=Si, Al, Sn), Fe—Mn—Si,Fe—Pt approx. 25 at. % Pt, Mn—Cu 5/35 at. % Cu, Ni—Fe—Ga, Ni—Ti approx.55-60 wt. % Ni, Ni—Ti—Hf, Ni—Ti—Pd, Ni—Mn—Ga, and Ti—Nb. While theexamples herein refer to nitinol, other alloys that exhibit shape memoryeffects may be used.

FIG. 4A is a cross section of an expandable balloon speculum 300A withan outer balloon layer 310 surrounding an inner balloon layer 320. Theinner balloon layer 320 surrounds and abuts a shape memory alloy meshlayer 330.

FIG. 4B is a cross section of an expandable balloon speculum 300B withan outer balloon layer 310 surrounding a shape memory alloy mesh layer330. The shape memory alloy mesh layer 330 surrounds and abuts the innerballoon layer 320.

FIG. 4C is a cross section of an expandable balloon speculum 300C withan outer balloon layer 310 abutting and surrounding a shape memory alloymesh layer 330. The shape memory alloy mesh layer 330 surrounds an innerballoon layer 320.

FIG. 4D is a cross section of an expandable balloon speculum 300D withan outer balloon layer 310 surrounding a shape memory alloy mesh layer330. The shape memory alloy mesh layer 330 surrounds the inner balloonlayer 320. The shape memory alloy mesh layer 330 is between, but doesnot abut, either the inner balloon layer 320 or the outer balloon layer310.

FIG. 5 is a perspective view of a speculum 400 showing a flared shapememory alloy mesh 430, with outer balloon layer 410, and inner balloonlayer 420. The shape memory alloy mesh 430 may be incorporated inspecula with cross sections corresponding to FIGS. 4A, 4B, 4C, and 4D.For clarity, FIG. 5 illustrates a speculum 400 with a cross sectioncorresponding to FIG. 4B, since the shape memory alloy mesh layer 430would be further obscured in perspectives of specula corresponding tothe cross sections of FIGS. 4A, 4C, and 4D by the inner balloon layer420.

FIG. 6 is a perspective view of the speculum 400 of FIG. 5 , with shapememory alloy mesh layer 430, before pumping in fluid from a syringe 200.The outer balloon layer 410 is not extended, as fluid has not yet beenpumped from the syringe 200 to the speculum 400 via access tube 470between the outer ball layer 410 and the inner balloon layer 420.

A valve 480 may be opened to allow fluid to flow from the syringe 200 tothe speculum 400. The speculum 400 has a proximal end 450 and a distalend 460. The syringe 200 expels fluid from the syringe tip 210, into theinsertion end of the access tube 170. The syringe body 215 receives aplunger 220, that, when depressed, pushes fluid out of the syringeliquid cavity 230. The syringe body 215 may include volume markings 240.The fluid injected from the syringe 200 into the speculum 100 may bewater, saline, a chemiluminescent fluid, air, or another liquid, gas, orgel-like substance.

FIG. 7 is a perspective view of the speculum 400 of FIG. 6 after pumpingin fluid 230 from the syringe 200. The expansion of the speculum 400 mayoccur because of heat expansion of the shape memory alloy 430 inaddition to the insertion of the fluid. In various embodiments, thefluid is a chemiluminescent fluid that emits light to illuminate atleast a portion of a patient's vaginal canal, such as her cervix, nearthe distal end 460 of the speculum 400.

A valve 480 may be opened to allow fluid to flow from the syringe 200 tothe speculum 400. The speculum 400 has a proximal end 450 and a distalend 460. The syringe 200 expels fluid from the syringe tip 210, into theinsertion end 490 of the access tube 170. The syringe body 215 receivesa plunger 220, that, when depressed, pushes fluid out of the syringeliquid cavity 230. The syringe body 215 may include volume markings 240.The fluid injected from the syringe 200 into the speculum 100 may bewater, saline, a chemiluminescent fluid, air, or another liquid, gas, orgel-like substance.

FIG. 8A illustrates an example of shape memory alloy mesh 800A. Theshape memory alloy may be formed of nitinol, or another shape memoryalloy.

FIG. 8B illustrates another example of a shape memory alloy mesh 800B.Various implementations may include the mesh structure of FIG. 8A, themesh structure of FIG. 8B, or another mesh structure.

The examples herein describe specula for viewing out of the distal endto examine and/or treat a patient through the distal end of the lumenformed by the speculum. In various embodiments, the distal end of thespeculum flares out, for a wider viewing angle of, for example, apatient's cervix. Similarly, the proximal end of the speculum may beflared out to allow for insertion of and manipulation of instrumentsthat are inserted into the lumen of the speculum, through the length ofthe speculum, towards the distal end of the speculum. The disclosedtechnology may also be applied to other medical devices, such asanoscopes or colonoscopes. For these devices, a health care provider mayneed to examine a patient lateral to the direction of travel of theanoscope or colonoscope, through the walls of the anoscope orcolonoscope instead of just through the distal end. For example, thewalls of the medical device may be clear or translucent, or they mayhave gaps or windows for viewing. For the case of a colonoscope, thiswould allow for observation of the colon walls during a colonoscopy.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. In this specification and inthe claims that follow, reference will be made to a number of terms thatshall be defined to have the following meanings:

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise.

“Optional” or “optionally” means that the subsequently described eventor circumstance can or cannot occur, and that the description includesinstances where the event or circumstance occurs and instances where itdoes not.

The term “about” when used before a numerical designation, e.g.,temperature, time, amount, concentration, and such other, including arange, indicates approximations which may vary by (+) or (−) 10%, 5%,1%, or any subrange or subvalue there between. Preferably, the term“about” when used with regard to a dose amount means that the dose mayvary by +/−10%.

“Comprising” or “comprises” is intended to mean that the compositionsand methods include the recited elements, but not excluding others.“Consisting essentially of” when used to define compositions andmethods, shall mean excluding other elements of any essentialsignificance to the combination for the stated purpose. Thus, acomposition consisting essentially of the elements as defined hereinwould not exclude other materials or steps that do not materially affectthe basic and novel characteristic(s) of the claimed invention.“Consisting of” shall mean excluding more than trace elements of otheringredients and substantial method steps. Embodiments defined by each ofthese transition terms are within the scope of this invention.

It should be noted that any ordering of method steps implied by thedrawings or description herein is not to be construed as limiting thedisclosed methods to performing the steps in that order. Rather, thevarious steps of each of the methods disclosed herein can be performedin any of a variety of sequences. In addition, as the described methodsare merely exemplary embodiments, various other methods that includeadditional steps or include fewer steps are also within the scope of thepresent disclosure.

Although the invention has been described by reference to specificembodiments, it should be understood that numerous changes may be madewithin the spirit and scope of the inventive concepts described.Accordingly, it is intended that the invention not be limited to thedescribed embodiments, but that it have the full scope defined by thelanguage of the following claims.

In the descriptions above and in the claims, phrases such as “at leastone of” or “one or more of” may occur followed by a conjunctive list ofelements or features. The term “and/or” may also occur in a list of twoor more elements or features. Unless otherwise implicitly or explicitlycontradicted by the context in which it is used, such a phrase isintended to mean any of the listed elements or features individually orany of the recited elements or features in combination with any of theother recited elements or features. For example, the phrases “at leastone of A and B;” “one or more of A and B;” and “A and/or B” are eachintended to mean “A alone, B alone, or A and B together.” A similarinterpretation is also intended for lists including three or more items.For example, the phrases “at least one of A, B, and C;” “one or more ofA, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, Balone, C alone, A and B together, A and C together, B and C together, orA and B and C together.” Use of the term “based on,” above and in theclaims is intended to mean, “based at least in part on,” such that anunrecited feature or element is also permissible.

The implementations set forth in the foregoing description do notrepresent all implementations consistent with the subject matterdescribed herein. Instead, they are merely some examples consistent withaspects related to the described subject matter. Although a fewvariations have been described in detail herein, other modifications oradditions are possible. In particular, further features and/orvariations can be provided in addition to those set forth herein. Forexample, the implementations described above can be directed to variouscombinations and sub-combinations of the disclosed features and/orcombinations and sub-combinations of one or more features further tothose disclosed herein. In addition, the logic flows depicted in theaccompanying figures and/or described herein do not necessarily requirethe particular order shown, or sequential order, to achieve desirableresults. The scope of the following claims may include otherimplementations or embodiments.

1-16. (canceled)
 17. A speculum, comprising: a shape memory alloy layer comprising a mesh, the shape memory alloy layer configured to transition to a first shape when heated above a transition temperature; an outer balloon layer continuously circumferentially surrounding the mesh; an inner balloon layer formed within the outer balloon layer, the outer balloon layer and the inner balloon layer forming a sealed cavity therebetween, at least a portion of the inner balloon layer translucent; a chemiluminescent liquid comprising a combination of a first solution and a second solution, the combination of the first and second solutions causing a light-emitting chemical reaction, wherein the sealed cavity is configured to hold the chemiluminescent liquid; and an access tube for injecting the chemiluminescent liquid into the cavity, the outer balloon layer configured to expand circumferentially in response to the injecting of the chemiluminescent liquid into the cavity.
 18. The speculum of claim 17, wherein the shape memory alloy comprises nitinol.
 19. The speculum of claim 17, wherein the inner balloon layer has a more rigid structure than the outer balloon layer.
 20. The speculum of claim 17, wherein the outer balloon layer comprises latex, rubber, silicon, or a flexible plastic.
 21. The speculum of claim 17, further comprising rods incorporated into the outer balloon layer in a longitudinal direction, the rods being flexible.
 22. The speculum of claim 21, wherein the rods comprise silicon.
 23. The speculum of claim 17, wherein the shape memory alloy layer abuts the inner balloon layer.
 24. The speculum of claim 17, wherein the shape memory alloy layer surrounds the inner balloon layer.
 25. The speculum of claim 17, wherein the inner balloon layer surrounds the shape memory alloy layer.
 26. The speculum of claim 17, wherein the outer balloon layer surrounds the shape memory alloy layer.
 27. The speculum of claim 17, wherein the outer balloon layer abuts the shape memory alloy layer.
 28. The speculum of claim 17, further comprising a valve to regulate a flow of fluid from a syringe into the access tube.
 29. The speculum of claim 17, wherein the inner balloon layer forms a tube shaped lumen.
 30. The speculum of claim 17, wherein the first solution comprises at least one of luminol, sodium carbonate, copper sulfate, and ammonium carbonate, and wherein the second solution comprises hydrogen peroxide.
 31. The speculum of claim 17, further comprising: a glass tube containing the first solution, and a plastic tube containing the second solution and the glass tube, wherein bending the plastic tube containing the glass tube breaks the glass tube without breaking the plastic tube, wherein breaking the glass tube causes the light-emitting chemical reaction in response to a mixing of the first and second solutions.
 32. The speculum of claim 17, further comprising: an interior balloon containing the first solution, and an exterior balloon containing the second solution and the interior balloon, wherein distortion of the exterior balloon containing the interior balloon breaks the interior balloon without breaking the exterior balloon, wherein breaking the interior balloon causes the light-emitting chemical reaction in response to a mixing of the first and second solutions.
 33. The speculum of claim 17, further comprising a receptacle with a septum separating the first solution from the second solution, the receptacle and septum configured to allow injection of the first and second solutions into a cavity, wherein the injection of the first and second solutions into the cavity causes the light-emitting chemical reaction in response to a mixing of the first and second solutions.
 34. The speculum of claim 17, wherein the chemiluminescent liquid emits light in response to an electric current.
 35. The speculum of claim 17, wherein the chemiluminescent liquid emits light in response to ultrasonic stimulation.
 36. A system comprising the speculum of claim 17 and an applicator, wherein the applicator is configured to insert the speculum into a vaginal canal. 